Transfer device and cap assembly for use with a container and the transfer device

ABSTRACT

The present invention is directed to a transfer device for fluid communication between a first site and a second site comprising a housing, a fluid channel and typically a sleeve assembly. The housing has a first end being connectable to the first site, a second end being connectable to the second site and a longitudinal portion extending between the first and second ends and defining a longitudinal axis. The housing includes two oppositely arranged wings comprising engaging means for engagement with the first site. The fluid channel is provided in the housing for fluid communication between the first end and the second end of the housing. The optionally provided sleeve assembly is mounted to the housing and axially movable relative to and biased against the housing.

This application claims priority benefit under Title 35 § 119(e) of U.S.provisional Application No. 60/341,733 filed Dec. 17, 2001 and U.S.provisional Application No. 60/359,917 filed Feb. 26, 2002. The presentinvention relates to a transfer device and in particular to a transferdevice for fluid communication between a first site and a second site.Moreover, the present invention relates to a cap assembly for use with acontainer and a transfer device.

EP-A-0 114 677 discloses a connector comprising a tubular body portion,in which a plug carries a pointed needle. The body portion has externalprojections which carry deflectable locking arms for engagement with aninjection site when the needle is inserted into a septum of the site.The arms prevent accidental disengagement of the needle from the septum.

EP-A-0 544 654 relates to a blunt cannula device whose piercing membercannot accidentally disengage from the septum in use. The blunt cannuladevice disclosed in EP-A-0 544 654 comprises a pair of locking memberswherein each locking member is a manually operable spring-likedeflectable arm having manually grippable means at one end and means atthe opposite end for engagement with the injection site when thepiercing member of the cannula device is inserted into the septum.Furthermore, the cannula device comprises a cross member having the bodyportion extending from one side thereof and the piercing memberextending from the opposite side thereof such that the cross memberextends radially between the body portion and the piercing member. Eachlocking member is fixed between its ends to a respective end of thecross member.

WO 98/37854 discloses a cap assembly for a container having a penetratordisposed within a cavity of the housing of the cap assembly. Thepenetrator is moveable between a retracted position completely withinthe cavity of the housing and an extended position in which thepenetrator projects from the lower end of the hollow housing. If asyringe is engaged with a luer lock thread system on the housing, and ifrelative rotation is effected between the syringe and the container, themale member of the syringe moves downwardly against the upper end of thepenetrator. This pushes the penetrator downwardly along the cavity inthe housing.

WO 98/32411 discloses a luer connector comprising a luer connectable toa syringe and which extends to a sharpened end capable of being driventhrough a punctuable vial closure. The luer connector further comprisesa luer support being mountable on a vial, and which initially supportsthe luer in a first position in which the sharpened end of the conduitis pointed toward the closure. Finally, the connector comprises a luerdriver such that movement of the driver relative to the support causesthe luer to be driven so that the sharpened end punctures the closureand enters the vial.

EP-A-0 829 249 relates to a vial connector assembly for transfer of aliquid. The connector assembly comprises a transfer tube that isslideably moveable between a distal position and a proximal position.

JP-A-03-039162 describes an injection drug dissolving solution containercomprising an injection needle having two liquid passages. In use, oneof the two passages becomes the passage of the dissolving solution, andthe other of the two passages becomes that of air.

EP-A-0 829 250 discloses a connector assembly mountable to the neck of avial. The connector assembly comprises a collar mountable to the rim ofthe vial neck between a first position, wherein the collar is removablysecured to the rim of the vial neck, and a second position, wherein thecollar is fixedly secured to the rim of the vial neck. A protective capof the connector assembly is mountable about the sidewall portion of thecollar. A ring is provided adjacent the open proximal end of the cap andis connected thereto by a user-severable connection. The cap has aremovable position and an engagement position. In the removableposition, the collar is in said first position and the cap is mountableto the collar. When the cap is in its engagement position, the cap isurged in a proximal direction in order to secure the collar in saidsecond position.

EP-A-0 904 763 discloses a connector assembly for a vial. The connectorassembly comprises a protective cap having an open proximal end, and acollar provided adjacent the open proximal end of the protective cap.Furthermore, a locking ring is provided between the collar and the rimof the vial. A cooperative locking structure is provided between thecollar and the locking ring to retain the locking ring in a lockedposition respective of the collar.

The object of the present invention is to provide an improved transferdevice for fluid communication between a first site and a second site.

A further object of the present invention is to provide an improvedmethod for transferring fluid from a first site to a second site.

It is a further object of the present invention to provide an improvedcap assembly for use with a container and a transfer device.

It is a further object to provide an improved method of mounting theimproved cap assembly to a container.

According to a first aspect of the present invention, a transfer devicefor fluid communication between a first site and a second site isprovided. The transfer device comprises:

-   -   a) a housing having a first end being connectable to the first        site, a second end being connectable to the second site and a        longitudinal portion between the first and second ends defining        a longitudinal axis, the housing including two oppositely        arranged wings comprising engaging means for engagement with the        first site;    -   b) a fluid channel provided in the housing for fluid        communication between the first end and the second end of the        housing; and    -   c) a sleeve assembly mounted to the housing, the sleeve assembly        being axially movable relative to and biased against the        housing;    -   wherein the fluid channel comprises at least one needle        extending from the housing along the longitudinal axis, the        needle being completely accommodated in the sleeve assembly,        when the device is non-actuated, and the needle protruding from        the sleeve assembly, when the device is axially compressed        against the biasing force so as to move the sleeve assembly        relative to the housing.

In a preferred form of the transfer device, the sleeve assemblycomprises an inner sleeve and an outer sleeve defining a space betweenthem, the biasing force being provided by a compression spring that ispartially accommodated in the space between the inner and outer sleeves.More preferably, the sleeve assembly comprises a membrane blockingaccess to the interior of the sleeve assembly in which the at least oneneedle is provided. In a further preferred form of the transfer devicethe sleeve assembly and the housing comprise complementary guiding meansfor guiding the axial movement of the sleeve assembly relative to thehousing. Preferably, the guiding means comprise at least onelongitudinal slot provided in the housing and a retention tab providedon the sleeve assembly, the retention tab having a radially protrudingportion extending into the slot. In a preferred embodiment, the transferdevice further comprises a ventilation duct provided in the housing forallowing air to enter the first site. Preferably, the fluid channel andthe ventilation duct are arranged substantially in parallel with respectto one another. More preferably, the fluid channel and the ventilationduct are arranged co-axially at least along a part of their length.Preferably, each of the fluid channel and the ventilation duct comprisea hollow needle. According to a preferred embodiment, the ventilationduct comprises a filter element that is provided in an inlet opening ofthe ventilation duct.

According to a second aspect of the present invention, a transfer devicefor fluid communication between a first site and a second sitecomprises:

-   -   a) a housing having a first end being connectable to the first        site, a second end being connectable to the second site and a        longitudinal portion between the first and second ends defining        a longitudinal axis, the housing including two oppositely        arranged wings comprising engaging means for engagement with the        first site;    -   b) a fluid channel provided in the housing for fluid        communication between the first end and the second end of the        housing; and    -   c) a ventilation duct provided in the housing for allowing air        to enter the site from which fluid is transferred;    -   wherein the fluid channel and the ventilation duct are arranged        substantially in parallel with respect to one another. In a        preferred form of the transfer device the fluid channel and the        ventilation duct are arranged co-axially at least along a part        of their length. Preferably, each of the fluid channel and the        ventilation duct comprise a hollow needle. More preferably, the        ventilation duct comprises a filter element that is provided in        an inlet opening of the ventilation duct.

According to a third aspect of the present invention, a transfer devicefor fluid communication between a first site and a second sitecomprises:

-   -   a) a housing having a first end being connectable to the first        site, a second end being connectable to the second site and a        longitudinal portion between the first and second ends defining        a longitudinal axis, the housing including two oppositely        arranged wings comprising engaging means for engagement with the        first site; and    -   b) a fluid channel provided in the housing for fluid        communication between the first end and the second end of the        housing;    -   wherein each of the wings is pivotally hinged to the housing and        comprises a bridge section and a wing section, the bridge        section having two opposing ends and an intermediate part, and        the wing section being connected to the bridge section and        having a substantially curved shape so that end portions of the        wings are further spaced from the housing than a center portion        located between the end portions. Preferably, the hinge        resiliently biases the wing in a potential engaging position. In        a preferred form, the bridge section is hinged to the housing at        one of its ends and comprises on its other end a claw being        engagable with the engaging means provided on the first and/or        second site. Preferably, the curved wing section is connected to        the intermediate part of the bridge section. The curved wing        section preferably comprises a first curved portion being        connected to the bridge section and a second curved portion        extending from the first curved portion and forming a finger        grip region for actuating the wing.

According to a fourth aspect of the present invention, a transfer devicefor fluid communication between a first site and a second site,comprises:

-   -   a) a housing having a first end being connectable to the first        site, a second end being connectable to the second site and a        longitudinal portion between the first and second ends defining        a longitudinal axis, the housing including two oppositely        arranged wings comprising engaging means for engagement with the        first site;    -   b) a fluid channel provided in the housing for fluid        communication between the first end and the second end of the        housing; and    -   c) a sleeve assembly mounted to the housing, the sleeve assembly        being axially movable relative to and biased against the        housing;    -   wherein each of the wings is pivotally hinged to the housing,        and the engagement means being engaged with the sleeve assembly        in a non-actuated position such that the sleeve is axially        secured relative to the housing. Preferably, the engagement        means is formed as a claw. The sleeve assembly preferably        comprises a recess into which the claw of the wing engages.        Preferably, the sleeve assembly comprises a ramp adjacent the        recess, the ramp rising to the recess allowing a smooth travel        of the claw up to the recess, when the device is brought from an        actuated position into the non-actuated position.

According to a fifth aspect of the present invention, a transfer devicefor fluid communication between a first site and a second site, thedevice comprises:

-   -   a) a housing having a first end being connectable to the first        site, a second end being connectable to the second site and a        longitudinal portion between the first and second ends defining        a longitudinal axis, the housing including two oppositely        arranged wings comprising engaging means for engagement with the        first site;    -   b) a fluid channel provided in the housing for fluid        communication between the first end and the second end of the        housing; and    -   c) a sleeve assembly mounted to the housing, the sleeve assembly        comprising two oppositely arranged open ended slots extending        along the longitudinal axis and each having at least one        protrusion;    -   wherein each of the slots is adapted to receive a mating portion        of one of the sites from or into which fluid is to be        communicated, wherein the protrusion formed in each of the slots        secures the mating portion into place. The protrusion is        preferably a circumferentially extending protrusion which        narrows the width of the slot.

In all aspects of the present invention the first site is preferably acontainer, particularly a vial, from or into which fluid is to betransferred.

In a preferred form of all aspects of the invention, the second site isa suction operated dispenser device with which fluid is sucked out ofthe first site, through the transfer device and into the dispenserdevice and/or fluid is dispensed through the transfer device into thefirst site. Preferably, the suction operated dispenser device is asyringe.

In all aspects of the invention, the transfer device preferably furthercomprises luer connector for connection to at least one of the sites.Preferably, the luer connector comprises a luer lid, a luer plunger anda spring being supported by the housing and forcing the luer plungeragainst the luer lid so as to close the luer connector.

In all aspects of the invention, the first site preferably comprises acollar formed on the first site or a cap assembly mounted to the firstsite with which the wings are engagable.

According to a sixth aspect of the invention, the transfer device is acombination of any of the transfer devices of any of the previousaspects and preferred forms.

A seventh aspect of the invention relates to a method for transferringfluid from a first site to a second site using the transfer device ofany of the previous six aspects of the invention.

According to an eighth aspect of the invention, a cap assembly for usewith a container and a transfer device comprises:

-   -   a) a sleeve having an inner surface provided with at least two        axially spaced and radially inwardly extending protrusions that        are adapted to receive a radially outwardly extending collar of        the container therebetween so as to secure the cap assembly at        the container, and an outer surface provided with at least two        axially spaced annular grooves and at least one recess; and    -   b) a cap having a locking ring and a removable cap portion, the        locking ring comprising at least one inwardly extending        protrusion being adapted to mate with the annular grooves        provided on the outer surface of the sleeve.

Preferably, the locking ring and the removable cap portion areinterconnected by a line of weakness that is adapted to break uponremoval of the cap portion. Furthermore, it is preferred to provide thesleeve not as a continuously extending ring along its axial length butrather with legs that are adapted to snap over the collar of thecontainer. More preferably, the load to displace the legs of the sleeveis less than the load required for pushing the cap down.

In a preferred form, the locking ring removably holds the cap portion bya thread. More preferably, the locking ring is elastically deformable sothat the inwardly extending protrusion of the cap snaps into one of thegrooves. The recess provided on the outer surface of the sleeve ispreferably formed as an annular groove. Preferably, the recess providedon the outer surface of the sleeve is adapted to mate with an engagingmeans provided at the transfer device. One of the two axially spacedannular grooves is preferably located adjacent a lower end of the sleeveand the at least one recess is located adjacent an upper end of thesleeve, while the other groove is positioned relatively close to the atleast one recess.

In a preferred form, the sleeve comprises a stop member forming anabutment for the locking ring.

According to yet another aspect of the present invention, a method ofmounting the cap assembly to a container comprises the steps of:

-   -   a) pushing the cap assembly onto a collar of a neck provided on        the container so that the collar is accommodated between the two        inwardly extending annular protrusions of the sleeve, while the        cap is in a mounting position in which the inwardly extending        protrusion of the locking ring is engaged with an upper one of        the two grooves formed on sleeve; and    -   b) pushing the cap from the mounting position into a locking        position in which the cap assembly is secured to the container,        wherein in the locking position the inwardly extending        protrusion of the locking ring is engaged with a lower one of        the two grooves formed in the sleeve.

Preferably, the method comprises the additional step of:

-   -   c) removing the cap portion of the cap assembly from the locking        portion so as to expose the at least one recess for engagement        with engaging means of a transfer device.

In the following, preferred embodiments of the transfer device and thecap assembly of the present invention will be described with referencesto the drawings, in which:

FIG. 1 is an exploded isometric view of a preferred embodiment of thetransfer device of the present invention;

FIG. 2A is a side view of the transfer device of FIG. 1;

FIG. 2B is a cross-sectional view along line A-A of FIG. 2A;

FIG. 3A is a front view of the transfer device of FIG. 1;

FIG. 3B is a cross-sectional view along B-B of FIG. 3A;

FIGS. 4A to 4E are cross-sectional views of a preferred embodiment ofthe cap assembly of the present invention illustrating how the capassembly is assembled onto a vial;

FIGS. 5A to 5C show an embodiment of the cap assembly of the presentinvention assembled to vials of different sizes;

FIG. 6 is an isometric view of a preferred embodiment of the housing ofthe transfer device;

FIGS. 7A, 7B are cross-sectional views of two profiles of the innerhousing portion of the housing of the transfer device; and

FIGS. 8A, 8B are isometric views of the inner sleeve of the transferdevice.

The components of the transfer device 2 of the present invention will bedescribed in the following with reference to FIGS. 1 to 3. The transferdevice 2 is generally adapted for fluid communication between a firstsite, e.g., a bottle, container or vial, and a second site, e.g. asuction operated dispenser device such as a syringe. More precisely, thetransfer device 2 of the present invention can be advantageously usedfor the transfer of fluid (i.e. gas or liquid) from a container into asyringe whereby fluid is sucked out of the container through thetransfer device 2 and into the syringe. Similarly, the device can beused for the transfer of fluid from the syringe, through the transferdevice 2 into the same or a different container, for example an infusionbag, representing the first site.

The transfer device 2 shown in FIG. 1 comprises a housing 4 which ispreferably made of plastic material. The housing 4 has two oppositelyarranged wings 6 and 8, each comprising engaging means 10 and 12 forengagement with the first site, e.g. a collar of a container, vial orcap assembly. Preferably, the engaging means 10 and 12 are formed asclaws which can be engaged with the collar of a container. Each of thewings 6 and 8 is typically pivotally hinged to a main portion 14 of thehousing 4. This is preferably accomplished by an appropriate selectionof the material in combination with the construction of the wings 6 and8 in the respective hinge regions 16 and 18. For example, the materialof the wings 6 and 8 may be an elastic plastic material so that thewings can be bent around the hinge portions 16 and 18 in order to engageand disengage the claws 10 and 12. In order to effectively accomplishthe engagement and disengagement function of the wings 6 and 8, each ofthe wings preferably comprises a bridge section 20 and 22 and a wingsection 24 and 26. Each of the bridge sections 20 and 22 has twoopposing ends, namely the hinge portions 16, 18 and the engaging meansor claws 10, 12. The ends of the bridge sections 20 and 22 areinterconnected by respective intermediate parts. Each of the wingsections 24 and 26 is connected to the respective bridge sections 20 and22, preferably at the intermediate part thereof. Furthermore, the wingsections 24 and 26 have preferably a substantially curved shape that canbest be seen in FIGS. 2B and 3A. As shown in these figures, each of thecurved wing sections 24 and 26 may comprise a first curved portion 28,30 connected to the intermediate part of the bridge sections 20, 22 anda second curved portion 32, 34 extending from the first curved portions28, 30 and forming a finger grip region for actuating the wings 6, 8.The first curved portion 28, 30 is adapted for being gripped by thefingers of a user in order to force the claws 10, 12 in their engagedposition. This provides an additional safety feature when the transferdevice 2 is mounted to a container, vial or cap assembly because theuser can thus actively assist the engagement between the transfer device2 and, e.g., the container, while holding the arrangement.

However, instead of this curved construction of the wing sections 24,26, any construction may be used in connection with the presentinvention as long as the end portions of the wing sections adjacent tothe hinge portions 16 and 18 are further spaced from the housing 4 thanthe opposite ends of the wings 6 and 8. This construction is consideredparticularly advantageous since the engaging means 10 and 12 of thewings 6 and 8 can be opened further than in known devices in which thefinger grip regions of the wings are arranged equidistantly from thebody of the transfer device (see, e.g., EP 0 544 654 B1).

The housing 4 of the transfer device 2 of present invention furthermorecomprises two oppositely arranged housing portions 36 and 38, only oneof which can be seen in FIG. 1. These housing portions 36 and 38 arepreferably arranged circumferentially inbetween the wings 6 and 8.Housing portions 36 and 38 are mounted to the main portion 14 of thehousing 4 and are preferably integral therewith. Each of the housingportions 36 and 38 comprises a longitudinal slot 40 forming the firstpart of complementary guiding means for guiding an axial movement of asleeve assembly 42 relative to the housing 4.

As can thus be seen in FIG. 2B, the transfer device of the presentinvention comprises a fluid channel 44 provided in and extending throughthe housing 4 for fluid communication between the first site and thesecond site. More precisely, this fluid channel 44 extends substantiallyalong a longitudinal axis 46 of the device through the housing 4. Thefluid channel 44 preferably comprises at least one needle 48, forming anextension of the channel, wherein the needle 48 extends from the housing4 substantially parallel to the longitudinal axis thereof. The needle 48is hollow and has a tip portion that, upon engagement of the transferdevice 2 of the present invention with a fluid container, extends atleast partially into the fluid so that the fluid can be transferredthrough the hollow needle 48 and the fluid channel 44 provided in thehousing 4 to the second site (e.g. a syringe).

Furthermore, the housing 4 preferably comprises a ventilation duct 50for allowing air to enter into the first site (e.g. the container) fromwhich fluid is removed. Similarly, as in case of the fluid channel 44,the ventilation duct 50 preferably comprises a needle 52 that extendsfrom the housing in a substantially longitudinal direction. The fluidchannel 44 and the ventilation duct 50 are arranged substantiallyparallel with respect to one another, as can best be seen in FIG. 2B. Inparticular, the needles 48 and 52 are arranged substantially parallelwith respect to one another and can in fact be arranged co-axially. Theventilation duct 50 may comprise a filter element 54 being mounted in aninlet opening 56 provided in the housing 4 of the transfer device 2.This inlet opening 56 is preferably also arranged parallel to the fluidchannel 44 and the ventilation duct 50.

The transfer device 2 of the present invention furthermore preferablycomprises a luer connector 58 for connecting the device to the secondsite, in particular to a suction operated dispenser device like asyringe. The luer connector 58 comprises a luer lid 60, a luer plunger62 and a spring 64. The spring is a compression spring supported on itsone end by the housing 4 and acting with its other end on the luerplunger so as to force the luer plunger 62 against the luer lid 60 inorder to close the luer connector 58. Preferably, the luer lid 60comprises on its outer circumference a thread 66 to which the secondsite can be connected.

As already briefly mentioned above, the sleeve assembly 42 is axiallymoveable relative to the housing 4. Additionally, the sleeve assembly 42is biased against the housing 4 by means of a compression spring 68. Thecompression spring is supported with one of its ends by the housing 4while the other end acts on the sleeve assembly 42 so as to force thesleeve assembly in a non-actuated or extended position, respectively.From this non-actuated position the sleeve assembly may be pushedagainst the force of the compression spring 68 so as to move relative tothe housing 4 in an actuated position. In the non-actuated position theneedles 48 and 52 extending from the housing 4 are completelyaccommodated within the sleeve assembly 42 as can be clearly seen inFIG. 2B. This provides a safety feature because the user cannotaccidentally be contacted by the needles. Accordingly, in thenon-actuated position the entire fluid channel 44 and the ventilationduct 50 and particularly the needles 48 and 52 are not accessible fromthe outside and are therefore kept clean. If the transfer device 2 is tobe kept sterile, it is typically sterilely held in a packaging.

The sleeve assembly 42 advantageously comprises an inner sleeve 70 andan outer sleeve 72 defining a space 74 inbetween. The compression spring68 acting on the sleeve assembly 42 is at least partially accommodatedwithin the space 74 provided between the inner and outer sleeves 70 and72. The outer sleeve 72 is mounted to the inner sleeve by means of a rim76 provided on the inner sleeve and extending into a recess or slot 78formed in the outer sleeve 72. Furthermore, the sleeve assembly 42advantageously comprises a membrane 80 blocking access to the interiorof the sleeve assembly. This provides an additional safety feature. Theaxial movement of the sleeve assembly relative to the housing 4 ispreferably guided by complementary guiding means already referred toabove. One of the guide elements of the complementary guiding means isthe slot 40 provided in each of the housing portions 36 and 38. Thesecond part of this complementary guiding means is formed by twooppositely arranged retention tabs 82 and 84 that protrude from theouter circumference of the outer sleeve 74 of the sleeve assembly 42 andextend into the longitudinal slots 40 of the housing members 36 and 38.This can best be seen in FIGS. 3A and 3B. With these retention tabs 82and 84 the sleeve assembly is securely mounted to the housing 4 andaxially moveable relative to it. In addition to the complementaryguiding means, the sleeve assembly 42 is preferably additionally guidedalong the inner circumferential face of the inner sleeve 70. Moreprecisely, the housing 4 may comprise an inner housing portion 86 inwhich on the one hand the fluid channel 44 and the ventilation duct 50are provided, and on which the inner sleeve 70 of the sleeve assembly 42slides. This configuration can best be seen in FIGS. 2B and 3B.Advantageously the sleeve 70 and/or the inner housing portion 86comprise one or more radial protrusions that form an abutment for themaximum extension of the sleeve assembly 42 relative to the housing 4.

As shown in FIGS. 2B and 7A, the inner housing portion 86 of the housing4 has a substantially circular configuration. In particular FIG. 7Ashows the circular cross-section of the inner housing portion 86 withits two channels, i.e., the fluid channel 44 and the ventilation duct50. FIGS. 6 and 7B show an alternative design of the inner housingportion 86′. In this preferred form, the inner housing portion 86′comprises two opposite areas 861 of reduced wall section. The innerhousing portion 86′ is thus more H-shaped than circular. As shown in thedrawings, the areas of reduced wall section have essentially the form oflongitudinal grooves extending along the axis of the inner housingportion 86′. This particular design of the inner housing portion 86′ isadvantageous in that is contributes to reduce the cycle-time duringmanufacturing of the transfer device (the cycle-time is the time takenfor the tool to close, the injection of the plastic, the cooling of thepart and finally the ejection of the part from the tool). FIGS. 8A and8B show the two designs of the inner sleeve 70, 70′ being adapted to thespecific profile of the inner housing portion 86, 86′. FIG. 8A shows theessentially cylindrical inner sleeve 70 being adapted to the cylindricalprofile of the inner housing portion 86. FIG. 8B shows the modifieddesign of the inner sleeve 70′ having substantially longitudinal groovesin the outer surface of the sleeve and extending along the longitudinalaxis of the sleeve. The grooves have a sufficient depth so that theinner cylindrical surface of the sleeve comprises longitudinal webs 761that fit the profile of the modified inner housing portion 86′.

Furthermore, it is particularly advantageous that the engagement meansor claws 10 and 12 of the wings 6 and 8 are resiliently biased into apotential engaging position by means of the hinge portions 16 and 18 sothat without activating the wings the transfer device 2 of the presentinvention is always kept in its engaged position. Besides the fact thatwith this construction the device is always safely kept on the firstsite, this has the advantage that the claws 10 and 12 of the wings 6 and8 may effectively block the axial movement of the sleeve assemblyrelative to the housing 4. To this end the sleeve assembly 42 may beprovided with one or more recesses which are preferably two oppositelyarranged recesses 88, 90 into which the claws 10 and 12 of the wingsengage in the non-actuated position of the transfer device 2. This isbest illustrated in FIG. 3A. This engagement of the claws in therecesses in the non-actuated position of the transfer device 2 providesa further safety feature for protecting the user and the needles.Accordingly, in order to bring the transfer device 2 of the presentinvention to its actuated position the finger grip region 32 and 34 ofthe wings 6 and 8 have to be pressed together so as to pivot the claws10 and 12 out of the recesses 88 and 90, whereby the sleeve assembly 42will be axially moveable relative to the housing 4. It may also beadvantageous to provide ramps 92 and 94 adjacent to the recesses 88 and90 allowing a smooth travel of the claws 10 and 12 into the recesses 88and 90 when the device is brought from an actuated position into thenon-actuated position.

Additionally, it may be advantageous for certain applications of thetransfer device of the present invention to provide the sleeve assembly42 with two oppositely arranged open-ended slots 96 and 98 extendingparallel to the longitudinal axis 46 of the transfer device 2. Along thelength of each of the open-ended slots 96 and 98 at least one protrusion100 is provided that preferably extends in a circumferential directionso as to narrow the width of the slots 96, 98. The slots 96 and 98 incombination with their protrusion are adapted to receive a matingportion of the first site from or into which fluid is to becommunicated, wherein the protrusion 100 formed in each of the slots 96,98 secures the mating portion into place. More precisely, the matingportion of the first site may comprise two oppositely extending tabsformed on a substantially cylindrical neck of a container, e.g., aninfusion bag, wherein each of the tabs extends in a corresponding one ofthe slots 96 and 98 so as to be securely held on the transfer device 2of the present invention by the protrusions 100. Preferably, thedistance between the end of the slot 96, 98 and the protrusion 100corresponds to the height of the tabs on the container neck.Furthermore, the width of the slot 96, 98 preferably corresponds to thewidth of the tabs. Other infusion bags without such a mating portion aretypically held in the sleeve assembly 42 by friction. With such infusionbags (first site) slots 96, 98 are not necessary, although they wouldnot be of any disadvantage.

In the following, a cap assembly 102, which can advantageously be usedin combination with the transfer device 2 of the present invention, willbe described with reference to FIGS. 4 and 5. The cap assembly 102essentially comprises a sleeve 104 that is adapted to be mounted on acontainer 106. The sleeve 104 has an inner surface that is provided witha first radially inwardly extending protrusion 108 and at least a secondradially inwardly extending protrusion 110. The protrusions 108 and 110are preferably formed as annular protrusions. These two protrusions 108and 110 are adapted to receive a radially outwardly extending collar 112of the container 106 in between so as to secure the cap assembly 102 atthe container 106. The axial distance between the first and secondprotrusions 108 and 110 corresponds substantially to the height of thecollar 112 so that the cap assembly 102 is relatively fixedly mounted onthe container 106.

Although not shown in the drawings the sleeve 104 is advantageously madeof a ring portion and a plurality of axially extending legs the areadapted to snap over the collar 112 of the container 106. Moreprecisely, the legs are constructed such that the load necessary todisplace the legs radially is less than the force required to push a cap114 of the cap assembly 102 down onto the sleeve.

The cap 114 has a locking ring 116 and a removable cap portion 118. Thelocking ring 116 comprises at least one inwardly extending protrusion122 (FIG. 4A). However, in some instances it may be preferred to providea second inwardly extending protrusion that is axially spaced from thefirst protrusion 122. This second protrusion is shown in FIG. 4A in formof the dashed line with the reference sign 120. Furthermore, the sleeve104 is provided on its outer surface with at least two recesses,preferably annular grooves 124 and 126, that are adapted to mate withthe inwardly extending protrusion 122 of the locking ring 116. Theannular grooves 124 and 126 are best shown in FIG. 4A in which the capassembly 102 is illustrated in the pre-assembled condition.

The locking ring 116 and the removable cap portion 118 of the cap 114are preferably interconnected by a line of weakness 128 which is adaptedto break upon removal of the cap portion 118 from the locking ring 116.Typically, the locking ring 116 is elastically deformable so that theinwardly extending protrusion 122 of the cap 114 can snap into thegrooves 124 and 126 of the sleeve 104. Similarly, the sleeve 104 itselfmay be elastically deformable so that it can be pushed over the collar112 of the container 112. This is advantageously achieved by means ofthe legs of the sleeve 104 (not shown).

The sleeve 104 of the cap assembly 102 furthermore comprises at leastone recess, preferably a third annular groove 130, that is provided onthe outer surface of the sleeve 104. More precisely, the at least onerecess or the preferred third annular groove 130 is located adjacent toan upper end of the sleeve 104 and adjacent to the first annular groove124, while the second annular groove 126 is axially spaced from it andprovided at a lower end of the sleeve 104. The sleeve 104 preferablycomprises a stop member 132 forming an abutment for the locking ring 116when it is assembled to the sleeve 104.

With reference to FIGS. 4A to 4E, it will be described in the followinghow the cap assembly 102 can be mounted to the container 104. If the capportion 114 of the cap assembly 102 is not initially mounted to thesleeve 104, a pre-assembling step may be required as shown in FIG. 4A.More precisely, the cap portion 114 is mounted to the sleeve 104 byco-axially pushing it onto the sleeve until the protrusion 122 snapsinto the first, upper annular groove 124. This condition of the collarsub-assembly or cap assembly 102 is shown in FIG. 4B. Next, the capassembly 102 is located over the container (e.g. vial) 106 and pushedonto the collar 112 of-the neck of the vial so that the collar 112 isaccommodated between the two inwardly extending annular protrusions 108and 110 of the sleeve 104. This is shown in FIG. 4C. In this conditionthe cap assembly 110 can be removed again from the container 106, ifnecessary, e.g., in order to fill the container 106. As a next step, thecap assembly 102 is pushed from the mounting position shown in FIG. 4Cinto a locking position illustrated in FIG. 4D. In this locking positionthe cap assembly is secured to the container 106, wherein the inwardlyextending protrusion 122 of the locking ring 116 is engaged with thesecond, lower annular groove 126 formed on the outer surface of thesleeve 104. In this condition, the cap assembly is unremovably mountedto the container 106 since the locking ring 114 blocks any radiallyoutwardly directed movement of the sleeve 104 that would occur if thecap assembly was tried to be pulled from the container 106. In order toget access to the interior of the container 106 the removable capportion 118 has to be removed from the locking ring 116, e.g. bybreaking the line of weakness 128 provided between these portions. Uponremoval of the cap portion 118 the at least one recess or the preferredthird annular groove 130 is exposed for engagement with the claws 10 and12 of the transfer device 2 of the present invention. This is shown inFIG. 4E where the container 106 with the mounted cap assembly 102 isready for use with the transfer device 2 in order to transfer fluid fromthe container 106 to a second site, e.g. a syringe.

In FIGS. 5A to 5C containers or vials 106 of different sizes are shown,on each of which the cap assembly 102 of the present invention has beenmounted. As can be seen upon a comparison of the cap assemblies 102shown in these figures, the outer dimensions of the cap assemblies 102are substantially identical, independent of the size of the collar 112of the vials 106. More precisely, the cap assemblies 102 of the presentinvention are adapted to differently sized collars 112 in that the twoaxially spaced and radially inwardly extending protrusions 108 and 110of the sleeve 104 are positioned more inwardly in case of collars 112having a smaller diameter, as shown in FIG. 5A and 5B, and moreoutwardly in case of a collar 112 having a larger diameter, as shown inFIG. 5C. Accordingly, for all these cap assemblies 102 shown in FIG. 5Ato 5C a transfer device 2 of the same size can be used, although thecontainers 106 and their collars 112 are of different sizes.

Finally, it will be described how fluid can be communicated between afirst site and second site by use of the transfer device 2 and thecollar assembly 102 of the present invention. As already described abovewith reference to FIG. 4A to 4E the transfer device 2 of the presentinvention is preferably used in combination with the cap assembly 102 ofthe present invention mounted to the container 106 representing a firstsite, from which or into which fluid is to be communicated.Nevertheless, the transfer device of the present invention may be usedwithout the cap assembly 2 so that the engaging means 10 and 12 engagedirectly with the collar 112 formed on the neck of a container 106. Inthis instance it may, however, be necessary to prolong the wings andparticularly the engaging means 10 and 12.

Consequently, while in the following the function of the transfer device2 will be described with reference to the cap assembly 102 it should bereadily understandable by the person skilled in the art that the samefunction of the transfer device 2 is also possible without the capassembly 102.

In order to transfer fluid, particularly a liquid (e.g. medicines), froma first site like the container or vial 106 shown in FIGS. 4 and 5, thesleeve assembly 42 is initially brought into contact with the upper endportion of the sleeve 104 of the cap assembly 102. Then, the wings 6 and8 of the transfer device 2 are actuated by pressing the finger gripregions 32 and 34 so that the claws 10 and 12 remove from the recesses88 and 90 and the sleeve assembly 42 is released from its fixedposition. Subsequently, the transfer device 2 is pushed against the vial106 so that the sleeve assembly 42 moves axially into the housing 4against the force of the compression spring 60. While the sleeveassembly 42 slides into the housing 4, the needle 52 of the ventilationduct 50 and the needle 48 of the fluid channel 44 penetrate through themembrane 80 and extend into the vial 106 so as to be immersed in theliquid provided therein. In this condition, the wings 6 and 8 can bereleased, wherein, due to the resiliency of the material and theconstruction of the hinge portions 16 and 18, the wings return to theirnon-actuated position in which the claws 10 and 12 engage with theannular groove 130 provided on the cap assembly 102 or directly with thecollar 112 of the container 106.

Subsequently or even prior to the mounting of the transfer device 2 tothe vial 106, a second site, particularly a suction operated dispenserdevice (e.g. a syringe), is mounted to the luer connector 58 provided atthe end portion of the housing 4 opposite to the vial 106. Upon mountingthe syringe to the luer connector 58 the luer plunger 62 is forced fromits closing position to an open position against the force of the spring64 so as to open the fluid channel 44 from the vial 106 to the syringe.In this condition fluid can be exchanged between the first site and thesecond site through the fluid channel 44, whereas, if necessary, air canenter or escape through the ventilation duct 50.

More precisely, when the transfer device 2 of the present invention ismounted to the first and second sites, in a first step the fluid issucked out of the vial 106 (first site), through the fluid channel 44comprising the needle 48 and into the suction operated dispenser deviceor syringe (second site). The syringe with the stored liquid from thevial 106 may then be removed from the luer connector 58 of the transferdevice 2 of the present invention and used elsewhere. Alternatively, thetransfer device 2 of the present invention may be removed from the vial106 by pressing the finger grip regions 32 and 34 of the wings 6 and 8together so as to release the transfer device 2 from the vial 106. Then,the transfer device may be mounted to another container, vial, tubing,infusion bag etc. now representing the first site either by mounting thedevice by means of the claws 10 and 12 to a corresponding groove orrecess or by providing a mating portion of the first site into theopen-ended slots 96 and 98 until the mating portion is held by theprotrusion 100 within these slots. The fluid stored within the suctionoperated dispenser device or syringe (second site) can then betransferred from there through the fluid channel 44 with its needle 48into the container, vial, tubing, infusion bag etc. (first site). Oncethe transfer of the fluid is finished the transfer device 2 of thepresent invention is typically removed from the first site and thesecond site, whereas the sleeve assembly moves again to its non-actuatedposition, i.e. to a position where it covers the needles 48 and 52 sothat they are not exposed to the environment.

Accordingly, the transfer device 2 of the present invention represents auseful tool for the transfer of liquids from a first site to a secondsite and vice versa which is particularly safe and easy to handle.Moreover, the transfer device 2 of the present invention can be used fora plurality of applications and is particularly suited for the transferof medicines (including but not limited to Paclitaxel, Carboplatin,biological agents, and the like) from a first site to a second site. Theuse of the transfer device 2 of the present invention is particularlyeasy in combination with the cap assembly 102 of the present inventionthat can be mounted to various kinds of containers or vials 106 andallows an easy and safe engagement of the transfer device with thecontainer or vial.

1-43. (canceled).
 44. A transfer device (2) for fluid communicationbetween a first site and a second site, the transfer device (2)comprising: a) a housing (4) having a first end being connectable to thefirst site, a second end being connectable to the second site and alongitudinal portion between the first and second ends defining alongitudinal axis (46), the housing (4) including two oppositelyarranged wings (6, 8) comprising engaging means (10, 12) for engagementwith the first site; b) a fluid channel (44) provided in the housing (4)for fluid communication between the first end and the second end of thehousing (4); and c) a sleeve assembly (42) mounted to the housing (4),the sleeve assembly (42) being axially movable relative to and biasedagainst the housing (4); wherein the fluid channel (44) comprises atleast one needle (48) extending from the housing (4) along thelongitudinal axis (46), the needle (48) being completely accommodated inthe sleeve assembly (42), when the transfer device (2) is non-actuated,and the needle (48) protruding from the sleeve assembly (42), when thetransfer device (2) is axially compressed against the biasing force soas to move the sleeve assembly (42) relative to the housing (4).
 45. Thetransfer device (2) of claim 44, wherein the sleeve assembly (42)comprises an inner sleeve (70) and an outer sleeve (72) defining a space(74) between them, the biasing force being provided by a compressionspring (68) that is partially accommodated in the space (74) between theinner and outer sleeves (70, 72).
 46. The transfer device (2) of claim44, wherein the sleeve assembly (42) comprises a membrane (80) blockingaccess to the interior of the sleeve assembly (42) in which the at leastone needle (48) is provided.
 47. The transfer device (2) of claim 44,wherein the sleeve assembly (42) and the housing (4) comprisecomplementary guiding means (40, 82) for guiding the axial movement ofthe sleeve assembly (42) relative to the housing (4).
 48. The transferdevice (2) of claim 47 , wherein the guiding means comprise at least onelongitudinal slot (40) provided in the housing (4) and a retention tab(82) provided on the sleeve assembly (42), the retention tab (82) havinga radially protruding portion extending into the slot (40).
 49. Thetransfer device (2) of claim 44 further comprising a ventilation duct(50) provided in the housing (4) for allowing air to enter the firstsite.
 50. The transfer device (2) of claim 49, wherein the fluid channel(44) and the ventilation duct (50) are arranged substantially inparallel with respect to one another.
 51. The transfer device (2) ofclaim 50, wherein the fluid channel (44) and the ventilation duct (50)are arranged co-axially at least along a part of their length.
 52. Thetransfer device (2) of claim 50, wherein each of the fluid channel (44)and the ventilation duct (50) comprise a hollow needle (48, 52).
 53. Thetransfer device (2) of claim 49, wherein the ventilation duct (50)comprises a filter element (54) that is provided in an inlet opening(56) of the ventilation duct (50).
 54. A transfer device (2) for fluidcommunication between a first site and a second site, the transferdevice (2) comprising: a) a housing (4) having a first end beingconnectable to the first site, a second end being connectable to thesecond site and a longitudinal portion between the first and second endsdefining a longitudinal axis (46), the housing (4) including twooppositely arranged wings (6, 8) comprising engaging means (10, 12) forengagement with the first site; b) a fluid channel (44) provided in thehousing (4) for fluid communication between the first end and the secondend of the housing (4); and c) a ventilation duct (50) provided in thehousing (4) for allowing air to enter the site from which fluid istransferred; wherein the fluid channel (44) and the ventilation duct(50) are arranged substantially in parallel with respect to one another.55. The transfer device (2) of claim 54, wherein the fluid channel (44)and the ventilation duct (50) are arranged co-axially at least along apart of their length.
 56. The transfer device (2) of claim 55, whereineach of the fluid channel (44) and the ventilation duct (50) comprise ahollow needle (48, 52).
 57. The transfer device (2) of claim 56, whereinthe ventilation duct (50) comprises a filter element (54) that isprovided in an inlet opening (56) of the ventilation duct (50).
 58. Atransfer device (2) for fluid communication between a first site and asecond site, the transfer device (2) comprising: a) a housing (4) havinga first end being connectable to the first site, a second end beingconnectable to the second site and a longitudinal portion between thefirst and second ends defining a longitudinal axis (46), the housing (4)including two oppositely arranged wings (6, 8) comprising engaging means(10, 12) for engagement with the first site; and b) a fluid channel (44)provided in the housing (4) for fluid communication between the firstend and the second end of the housing (4); wherein each of the wings (6,8) is pivotally hinged to the housing (4) and comprises a bridge section(20, 22) and a wing section (24, 26), the bridge section (20, 22) havingtwo opposing ends and an intermediate part, and the wing section (24,26) being connected to the bridge section (20, 22) and having asubstantially curved shape so that end portions of the wings (6, 8) arefurther spaced from the housing (4) than a center portion locatedbetween the end portions.
 59. The transfer device (2) of claim 58,wherein the hinge (16, 18) resiliently biases the wing (6, 8) in apotential engaging position.
 60. The transfer device (2) of claim 59,wherein each of the bridge sections (20, 22) is hinged to the housing(4) at one of its ends and comprises on its other end a claw (10, 12)being engagable with the engaging means provided on the first and/orsecond site.
 61. The transfer device (2) of claim 60, wherein each ofthe wing sections (24, 26) is connected to the intermediate part of thebridge sections (20, 22).
 62. The transfer device (2) of claim 61,wherein each of the wing sections (24, 26) comprises a first curvedportion being connected to the bridge sections (20, 22) and a secondcurved portion extending from the first curved portion and forming afinger grip region (32, 34) for actuating the wings (6, 8).
 63. Atransfer device (2) for fluid communication between a first site and asecond site, the transfer device (2) comprising: a) a housing (4) havinga first end being connectable to the first site, a second end beingconnectable to the second site and a longitudinal portion between thefirst and second ends defining a longitudinal axis (46), the housing (4)including two oppositely arranged wings (6, 8) comprising engaging means(10, 12) for engagement with the first site; b) a fluid channel (44)provided in the housing (4) for fluid communication between the firstend and the second end of the housing (4); and c) a sleeve assembly (42)mounted to the housing (4), the sleeve assembly (42) being axiallymovable relative to and biased against the housing (4); wherein each ofthe wings (6, 8) is pivotally hinged to the housing (4), and theengaging means (10, 12) being engaged with the sleeve assembly (42) in anon-actuated position such that the sleeve assembly (42) is axiallysecured relative to the housing (4).
 64. The transfer device (2) ofclaim 63, wherein each of the engaging means is formed as a claw (10,12).
 65. The transfer device (2) of claim 64, wherein the sleeveassembly (42) comprises a recess (88, 90) into which the engaging means(10, 12) of the wings (6, 8) engages.
 66. The transfer device (2) ofclaim 65, wherein the sleeve assembly (42) comprises a ramp (92, 94)adjacent the recess, the ramp (92, 94) rising to the recess (88, 90)allowing a smooth travel of the engaging means (10, 12) into the recess(88, 90), when the transfer device (2) is brought from an actuatedposition into the non-actuated position.
 67. A transfer device (2) forfluid communication between a first site and a second site, the transferdevice (2) comprising: a) a housing (4) having a first end beingconnectable to the first site, a second end being connectable to thesecond site and a longitudinal portion between the first and second endsdefining a longitudinal axis (46), the housing (4) including twooppositely arranged wings (6, 8) comprising engaging means (10, 12) forengagement with the first site; b) a fluid channel (44) provided in thehousing (4) for fluid communication between the first end and the secondend of the housing (4); and c) a sleeve assembly (42) mounted to thehousing (4), the sleeve assembly (42) comprising two oppositely arrangedopen ended slots (96, 98) extending along the longitudinal axis (46) andeach having at least one protrusion (1 00); wherein each of the slots(96, 98) is adapted to receive a mating portion of one of the sites fromor into which fluid is to be communicated, wherein the protrusion (100)formed in each of the slots (96, 98) secures the mating portion intoplace.
 68. The transfer device (2) of claim 67, wherein the protrusion(100) is a circumferentially extending protrusion which narrows thewidth of the slot (96, 98).
 69. The transfer device (2) of claim 1,wherein the first site is a container (106), particularly a vial, fromor into which fluid is to be transferred.
 70. The transfer device (2) ofclaim 69, wherein the second site is a suction operated dispenser devicewith which fluid is sucked out of the first site, through the transferdevice (2) an into the dispenser device and/or fluid is dispensedthrough the transfer device (2) into the first site.
 71. The transferdevice (2) of claim 70, wherein the suction operated dispenser device isa syringe.
 72. The transfer device (2) of claim 1 further comprisingluer connector (58) for connection to at least one of the sites.
 73. Thetransfer device (2) of claim 72, wherein the luer connector (58)comprises a luer lid (60), a luer plunger (62) and a spring (64) beingsupported by the housing (4) and forcing the luer plunger (62) againstthe luer lid (60) so as to close the luer connector (58).
 74. Thetransfer device (2) of claim 72, wherein the first site comprises acollar (112) or a cap assembly (102) mounted to the first site withwhich the wings (6, 8) are engagable.
 75. A method for transferringfluid from a first site to a second site using the transfer device (2)of claim
 1. 76. A cap assembly (102) for use with a container (106) anda transfer device, particularly a transfer device (2) of claim 1, saidcap assembly (102) comprising: a) a sleeve (104) having an inner surfaceprovided with at least two axially spaced and radially inwardlyextending protrusions (108, 110) that are adapted to receive a radiallyoutwardly extending collar (112) of the container (106) therebetween soas to secure the cap assembly (102) at the container (106), and an outersurface provided with at least two axially spaced annular grooves (124,126) and at least one recess (130); and b) a cap (114) having a lockingring (116) and a removable cap portion (118), the locking ring (116)comprising at least one inwardly extending protrusion (122) beingadapted to mate with said annular grooves (124, 126) provided on theouter surface of the sleeve (104).
 77. The cap assembly (102) of claim76, wherein the locking ring (116) and the removable cap portion (118)are interconnected by a line of weakness (128) that is adapted to breakupon removal of the cap portion (118).
 78. The cap assembly (102) ofclaim 77, wherein the locking ring (116) removably holds the cap portion(118) by a thread.
 79. The cap assembly (102) of any claim 78, whereinthe locking ring (116) is elastically deformable so that the inwardlyextending protrusion (122) of the cap (114) snaps into at least one ofthe grooves (124, 126).
 80. The cap assembly (102) of claim 79, whereinthe recess (130) provided on the outer surface of the sleeve (104) isformed as an annular groove.
 81. The cap assembly (102) of claim 80,wherein the recess (130) provided on the outer surface of the sleeve(104) is adapted to mate with an engaging means (10, 12) provided at thetransfer device (2).
 82. The cap assembly (102) of claim 81, wherein oneof the two axially spaced annular grooves (126) is located adjacent alower end of the sleeve (104) and the at least one recess (130) islocated adjacent an upper end of the sleeve (104), while the othergroove (124) is positioned relatively close to the at least one recess(130).
 83. The cap assembly (102) of claim 82, wherein the sleeve (104)comprises a stop member (132) forming an abutment for the locking ring(116).
 84. A method of mounting the cap assembly (102) of claim 83 to acontainer (106) comprising the steps of: a) pushing the cap assembly(102) onto a collar (112) of a neck provided on the container (106) sothat the collar (112) is accommodated between the two inwardly extendingannular protrusions (108, 110) of the sleeve (104), while the cap (114)is in a mounting position in which the inwardly extending protrusion(122) of the locking ring (116) is engaged with an upper one of the twogrooves (124) formed on sleeve (104); and b) pushing the cap (114) fromthe mounting position into a locking position in which the cap assembly(102) is secured to the container (106), wherein in the locking positionthe inwardly extending protrusion (122) of the locking ring (116) isengaged with a lower one of the two grooves (124, 126) formed in thesleeve (104).
 85. The method of claim 84 comprising the additional stepof: removing the cap portion (118) of the cap (114) from the lockingring (116) so as to expose the at least one recess (130) for engagementwith engaging means (10, 12) of a transfer device (2).